CMS Expands TEER Coverage Under NCD 363: What Cardiac Billing Teams Must Know for 2026
The Centers for Medicare & Medicaid Services has modified National Coverage Determination (NCD) 363, updating its Coverage with Evidence Development (CED) requirements for Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve. This is a significant policy update affecting structural heart programs, interventional cardiology practices, and hospital billing teams that submit claims for mitral valve repair procedures. If your program treats Medicare patients with mitral regurgitation, this policy governs whether CMS will pay—and the heart team credentialing requirements alone are enough to derail a claim if you're not prepared.
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation |
| Policy Code | NCD 363 (v3) |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | High |
| Specialties Affected | Interventional Cardiology, Cardiothoracic Surgery, Cardiac Anesthesiology, Heart Failure Cardiology, Structural Heart Programs |
| Key Action | Audit your heart team's documented credentials and case volume thresholds against NCD 363's updated requirements before March 12, 2026. |
What Is TEER and Why NCD 363 Matters for Medicare Billing
Transcatheter Edge-to-Edge Repair is a catheter-based procedure that approximates the anterior and posterior mitral valve leaflets using a clipping device—functionally replicating the surgical Alfieri stitch without open-heart surgery. For Medicare-eligible patients with symptomatic mitral regurgitation (MR), TEER represents a critical treatment option, and NCD 363 is the controlling coverage policy.
CMS covers TEER under Coverage with Evidence Development, meaning coverage is conditional. It's not a blanket benefit—it requires documentation of specific clinical criteria, FDA-approved devices, and a qualifying multidisciplinary heart team. Claims submitted without evidence of compliance with these conditions are subject to denial.
This is version 3 of NCD 363, effective March 12, 2026. Billing teams should treat this as a hard cutover date: claims for procedures on or after that date must reflect the updated criteria.
CMS Medical Necessity Criteria: Who Qualifies Under NCD 363
CMS covers TEER for two distinct patient populations, and the documentation requirements differ between them. Getting this wrong at the claim level—or in the medical record—is a fast path to denial.
Functional MR Patients must meet all of the following:
| # | Covered Indication |
|---|---|
| 1 | Symptomatic moderate-to-severe or severe functional MR |
| 2 | Persistent symptoms despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) |
| 3 | Cardiac resynchronization therapy (CRT) implemented if clinically appropriate |
| 4 | Independent evaluation and face-to-face examination by both the heart team interventional cardiologist and the heart team heart failure cardiologist (note: the heart failure cardiologist may substitute record review if the patient has an established relationship with an advanced heart failure cardiologist) |
Degenerative MR Patients must meet all of the following:
| # | Covered Indication |
|---|---|
| 1 | Significant symptomatic degenerative MR |
| 2 | The procedure must be furnished according to an FDA-approved indication |
For both populations, the procedure must be performed using a mitral valve TEER system with FDA Premarket Approval (PMA). This is a hard requirement—off-label or non-PMA devices will not satisfy coverage.
The Heart Team Requirement: NCD 363's Most Operationally Demanding Condition
The heart team credentialing requirements under NCD 363 are specific, documented, and verifiable by auditors. Every member must meet defined thresholds. Here's what CMS requires:
Cardiac Surgeon:
- ≥ 20 mitral valve surgeries per year, or ≥ 40 over two years, with at least 50% being mitral valve repairs
- Board eligible or certified in cardiothoracic surgery (or foreign equivalent)
Interventional Cardiologist:
- ≥ 50 career structural heart disease procedures, or ≥ 30 left-sided structural procedures per year
- ≥ 20 career trans-septal interventions, including 10 as primary or co-primary operator
- Board eligible or certified in interventional cardiology (or foreign equivalent)
Interventional Echocardiographer (cardiologist or anesthesiologist):
- ≥ 10 trans-septal guidance procedures and ≥ 30 structural heart procedures
- Board eligible or certified in transesophageal echocardiography with advanced training as required by the performing hospital
Heart Failure Cardiologist:
- Required for functional MR patients only
- Must have experience treating patients with advanced heart failure
Additionally, NCD 363 requires that each patient's suitability for surgical mitral valve repair, TEER, or palliative therapy be independently evaluated, documented, and made available to all heart team members. This isn't a soft expectation—it's a coverage condition. Missing documentation of this evaluation puts the claim at risk.
Coverage with Evidence Development: What the CED Designation Means for Your Program
CED coverage is not the same as standard coverage. Under CED, Medicare payment is tied to participation in data collection or registry requirements that CMS uses to build the evidence base. Programs must confirm their TEER procedures are being conducted in alignment with applicable CED requirements, which may include registry enrollment or outcomes reporting obligations.
This matters for revenue cycle because CED non-compliance isn't just a clinical issue—it's a billing issue. A procedure performed without meeting CED conditions may be considered non-covered regardless of whether the patient met the clinical criteria.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
Affected Codes
The policy document for NCD 363 (v3) does not list specific CPT or HCPCS procedure codes or ICD-10-CM diagnosis codes. CMS structural heart policies of this type are typically billed using existing cardiovascular intervention codes, but billing teams should reference their MAC's local billing guidance to identify the applicable CPT codes for TEER procedures under this NCD, and should not assume code coverage without verification.
If your MAC has issued companion guidance or a billing article for NCD 363 v3, that document will contain the applicable codes and should be read alongside this NCD.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Audit heart team credentials against NCD 363 thresholds now. Pull documented case volumes for your cardiac surgeon, interventional cardiologist, and interventional echocardiographer and compare them to the specific volume requirements above. Flag any gaps before March 12, 2026—credential deficiencies cannot be retroactively resolved after claims are submitted. |
| 2 | Create a pre-procedure documentation checklist for functional vs. degenerative MR. The coverage criteria differ by MR type. For functional MR patients, you need documented evidence of maximally tolerated GDMT, CRT evaluation, and independent evaluation by both the interventional cardiologist and heart failure cardiologist. For degenerative MR, confirm FDA-approved indication alignment. Build these into your pre-auth and case prep workflow. |
| 3 | Verify FDA PMA status of your TEER device before every case. CMS coverage is explicitly tied to use of an FDA PMA-approved TEER system. If your program uses or is evaluating new devices, confirm PMA status before the procedure—not after. |
| 4 | Contact your MAC for code-level billing guidance. Because NCD 363 v3 does not list specific CPT or HCPCS codes, reach out to your Medicare Administrative Contractor to confirm the correct procedure codes for claims submission and any applicable modifiers. |
| 5 | Confirm CED registry enrollment or data submission compliance. If your program is not currently enrolled in the applicable CED registry, do this immediately. CED non-compliance is a coverage-level issue, not just a compliance footnote. |
| 6 | Document the multidisciplinary suitability evaluation in the medical record. NCD 363 requires that each patient's candidacy for surgery, TEER, or palliative therapy be evaluated, documented, and shared across the heart team. Make sure this documentation exists in the chart—not just in meeting notes—before a claim goes out the door. |
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